Infinita launches a Montana board that accepts therapies after first-phase clinical trials
Infinita launches a Montana board that accepts therapies after first-phase clinical trials
The Montana ETRB will review requests for access to experimental therapies before conventional FDA approval. A developer can apply for $12 500 after the first phase, the initial trial in humans, which primarily evaluates safety.
On July 25, Infinita announced the launch of the Montana Experimental Treatment Review Board, or ETRB. The company stated its purpose directly in the announcement:
“Infinita has formed the first ETRB under Montana law. For $12 500, you can submit a therapy to our board after the first phase of clinical trials.”
There is now a public route for seeking early access to a therapy: the board’s website already links to an application form. The board assesses whether the intervention’s safety has been described adequately, how the patient will be monitored, and how informed consent has been documented. The listed participants include aging biologists Matt Kaeberlein and Felipe Sierra, bioethicist Jessica Flanigan, Jamie Justice of XPRIZE, and oncologist James Burke.
Montana law SB 535 establishes this pathway. It allows drugs, biological products, devices, and other interventions to be considered after successful completion of the first phase, provided that they are still being studied in an FDA-approved trial or have a documented safety record. The patient discusses available approved options with the treating physician, obtains the physician’s recommendation, and signs a consent form.
The law divides responsibilities among the board, the clinic, and the state. Under the Montana Department of Public Health and Human Services’ proposed rules, the board reviews the protocol, safety data, monitoring plan, and patient consent. A licensed experimental treatment center administers the treatment and reports serious adverse events to the department within five days.
In June, Niklas Anzinger described Próspera and Montana SB 535 as parts of a future pathway: an initial safety assessment in humans, followed by access through a U.S. state. That pathway now has a board, an application form, and named participants. The developer prepares a dossier on the therapy, the board reviews it, the clinic treats the patient, and the state receives safety reports.